BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ARCOS DISTAL STEM

    MDR report key: 22635773 · Received July 28, 2025

    Report

    Report Number
    0001825034-2025-02280
    Event Type
    Injury
    Date Received
    July 28, 2025
    Report Date
    August 21, 2025
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    LZO
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. UPDATED: G3, G6, H2, H6, H10. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. PART AND LOT IDENTIFICATION ARE NECESSARY FOR REVIEW OF DEVICE HISTORY RECORDS, NEITHER WERE PROVIDED. COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED WITHOUT PRODUCT IDENTIFICATION. MEDICAL RECORDS AND RADIOGRAPHS WERE IDENTIFIED WITHIN THE JOURNAL ARTICLE. THE JOURNAL ARTICLE WAS PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL TO CREATE A TIMELINE. REVIEW OF THE AVAILABLE RECORDS IDENTIFIED THE FOLLOWING: - IMAGES TAKEN 3 YEARS STATUS POST LEFT TOTAL HIP ARTHROPLASTY REVISION. ANTERIOR-POSTERIOR (AP) PELVIS (A) AND AP (B) AND LATERAL LEFT (C) HIP VIEWS SHOW ESTABLISHED NONUNION OF THE GREATER TROCHANTER ON THE LEFT. THREE CABLES (ZIMMER) ENCIRCLE THE PROXIMAL LEFT FEMUR WITH BREAKAGE OF ONLY THE MOST PROXIMAL ONE. 7 YEARS POSTOP, X-RAYS SHOWED BREAKAGE OF AN ADDITIONAL CABLE. BONE SCANS SHOWED NO AREAS OF INCREASED ACTIVITY TO SUGGEST DEEP INFECTION. SERUM TITANIUM LEVEL WAS 19.1 NG/ML. NO EVIDENCE OF DISPLACEMENT, LOOSENING, FAILURE, OR GROSS BREAKAGE OF THE STEM. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT IS CONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Additional Manufacturer Narrative · 0

    (B)(4). B3: JOURNAL ARTICLE WAS PUBLISHED IN AUGUST 2024. D10: UNKNOWN ARCOS PROXIMAL BODY UNKNOWN. SUGGESTED COMPONENT CODE: MECHANICAL (G04) - STEM. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. JOSEPHSON, BRIAN G. AB; DAMRON, TIMOTHY A. MD. ELEVATED TITANIUM LEVELS AFTER REVISION TOTAL HIP CAUSED BY PREVIOUSLY UNREPORTED MECHANISM. JAAOS: GLOBAL RESEARCH AND REVIEWS 8(8):E24.00001, AUGUST 2024. / DOI: 10.5435/JAAOSGLOBAL-D-24-00001.

    Description of Event or Problem · 0

    NO ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED FROM A JOURNAL ARTICLE THAT A PATIENT UNDERWENT A LEFT REVISION TOTAL HIP ARTHROPLASTY PERFORMED ON AN UNKNOWN DATE. SUBSEQUENTLY, THE PATIENT PRESENTED WITH PAIN AND ELEVATED SERUM TITANIUM LEVELS. X-RAYS SHOWED FRACTURE OF 2 CERCLAGE CABLES AND NONUNION OF THE GREATER TROCHANTER. NO FURTHER TREATMENT, INTERVENTION, OR FURTHER COMPLICATIONS WERE NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653024 UNK ARCOS DISTAL STEM PROSTHESIS, HIPS LZO ZIMMER BIOMET, INC. N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Other